Cleared Traditional

K943235 - IMMULITE DIGITOXIN

K943235 is an FDA 510(k) clearance for IMMULITE DIGITOXIN, manufactured by Diagnostic Products Corp.. The device is a Class 2 Toxicology device with product code LFM cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K943235 · Diagnostic Products Corp. · Toxicology device
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Oct 1994
Decision
113d
Days
Class 2
Risk

K943235 is an FDA 510(k) clearance for the IMMULITE DIGITOXIN. Classified as Enzyme Immunoassay, Digitoxin (product code LFM), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on October 27, 1994 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3300 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K943235

510(k) Number K943235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1994
Decision Date October 27, 1994
Days to Decision 113 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 87d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFM Device Classification - Class 2, Special Controls

Product Code LFM Enzyme Immunoassay, Digitoxin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - LFM Enzyme Immunoassay, Digitoxin

All 17
Devices cleared under the same product code (LFM) and FDA review panel - the closest regulatory comparables to K943235.
ABBOTT AXSYM DIGITOXIN (MODIFY)
K963158 · Abbott Laboratories · Sep 1996
AXSYM DIGITOXIN
K954420 · Abbott Laboratories · Dec 1995
DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS
K951631 · Bayer Corp. · Jun 1995
KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)
K942610 · Eastman Kodak Company · Oct 1994
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS
K942619 · Syva Co. · Sep 1994
DIGITOXIN FPIA REAGENT SET
K915465 · Sigma Diagnostics, Inc. · Jan 1992